A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

YL201: YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.

Atezolizumab: Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

Study summary

This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.

Eligibility

Primary outcome measure(s)

• Nature and Frequency with Dose-Limiting Toxicities (DLTs) — 21 days
• Adverse Events — First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
  Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5

Trial sites (38)

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